# STILLMEADOW I NCO R P 0 

### RAT E D

VOLUME OF OF SUBMISSION Alcohols, C18-22, distn. Residues (CAS No.1160164-88-4) FINAL REPORT**ACUT~** 

### DERMALTOXICITYSTUDY 1N RATS OECD402 AUTHOR: Janice O. Kuhn, 

### PhD, DABT STUDY INITIATION DATE: 11 September 2009 STUDY CONfPLETIONDATE: 27 October 2009 CONDUCTED BY: STILLMEADOW,Inc. 12852 Park OneDrive SugarLand, TX 77478 LABORATORY STUDYNUMBER: 

### 13293-09 VOLUME

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### --L OF STUDY PAGE

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## 11 SUBMITTED TO: Sasol Germany GmbH

Anckelmannsplatz 1 Hamburg, Germany 20537

12852 Park One Drive. Sugar Land, Texas 77498 • 281 240-8828 • Fax 281 240-8448 www.stillmeadow.com13293-09 Page 2 of 11 GOOD LABORATORYPRACTICE COMPLIANCE STATEMENT This study was designed and performed at STILLMEADOW, Inc. and was conducted in compliance with United States Environmental Protection Agency TSCA40 CFR 792 with exception of: 

### Section 792.31(d) and 792.105 (a)(b)(e) The provided Certificate of Analysis was not accompanied by a GLP compliance statement. This study was designed and performed at STILLMEADOW, Inc. and was conducted in compliance with Organization for Economic Cooperation & Development Principles of GLP, Annex 2, C(98)17 with exception of: 

### Section IT,Ll (2)(p), 6.1 (1) and 6.2 (2)(4) The provided Certificate ofAnalysis was not accompanied by a GLP compliance statement.. This study was designed and performed at STILLMEADOW, Inc. and was conducted in compliance with Japan Ministry ofAgriculture, Forestry & Fisheries, Notification No. 11 Nousan 6283, Director-General of Agricultural ProductionBureau with exception of: 

### Article 3.1 (18), 12.5 and 12.7 The provided Certificate of Analysis was not accompanied by a GLP compliance statement.


## o Kuhn, PhD, DABT D rector, STILLMEADOW, Inc. Signature ofAgent ofSponsor Agent Name Sponsor: Sasol Germany GmbH Signature ofAgent ofSubmitter AgentName Submitter: Sasol NA Date

Date

Date

STILLMEADOW, Inc.QUALITYASSURANCE STATEMENT Test Substance: Alcohols, C18-22, distn. Residues (CAS No.1160164-88-4) StudyTitle: Acute Dermal Toxicity Study in Rats 13293-09. Page 3 of 11

The study report and data have been audited in accordance with Good Laboratory·Practice Standards and STILLMEADOW, Inc. Standard Operating Procedures (SOPs). The fmal report accurately reflects the study data. The Quality Assurance Unit has notbeen involved inthe actual conduct ofthis study. The Quality Assurance Unit performed a recent facility inspection on 10 Jul 09. All fmdings were reported to Management, and the report and responses are kept inthe Quality Assurance files. The findings from any study inspections and audits were reported to the Study Director and Management as follows: CriticalPhase Inspected Date Inspected Reportedto Study Reported to Director Management ProtocolReview 08 Sep 09 08 Sep 09 08 Sep 09 Dosing 24 Sep 09 24 Sep 09 24 Sep 09 Report/Data Audit 20 Qct 09 20 Qct 09 20 Qct 09

ScottFeazell /0 Date Quality Assurance, STILLMEADOW, Inc.

STILLMEADOW,Inc.TABLE OF CONTENTS 13293-09 Page 4 of 11

GOOD LABORATORYPRACTICE COMPLIANCE STATEMENT ............................................................. 2 QUALITYASSURANCE STATEMENT.......................................................................................................... 

### 3 Su-MMARY ........................................................................................................................................................ 5 INTRODUCTION............................................................................................................................................... 5 TEST SUBSTANCE........................................................................................................................................... 5 TEST SySTEM................................................................................................................................................... 6 ExperimentalAnimals..................................................................................................................................... 6 Animal Husbandry .......................................................................................................................................... 6 PROCEDURES ................................................................................................................................................... 6 Test**Substan~e** Preparation and Administration.............................................................................................. 6 Removal ofTest Substance ............................................................................................................................. 7 In-life Observations....................................................,.................................................................................... 7 Dermal Irritation Observations........................................................................................................................ 7 Postmortem Observations................................................................................................................................ 7 RESULTS AND DISCUSSION ......................................................................................................................... 7 MortalitylEstimatedLDso Values....... _ ....................................:........................................................................ 7 Body Weights .................................................................................................................................................. 7 Clinical SignslDermal Irritation .............................................................. - ........................."............................. 7 NecropsyFindings........................................................................................................................................... 7 CONCLUSION .....................................................................................................................:............................. 8 SIGNATURE ...................................................................................................................................................... 8 STUDY PERSONNEL ....................................................................................................................................... 8 TABLE 1 - Body Weights, Time ofDeath and Gross Necropsy ........................................................................ 9 TABLE 2 - Pharmacologic and/or Toxicologic Signs ...................................................................................... 10 APPENDIX A - Certificate ofAnalysis............................................................................................................ 11

STILLMEADOW, Inc.SUMMARY 13293-09 Page 5 of 11

The test substance, Alcohols, C18-22, distn. Residues (CAS No.l160164-88-4), was evaluated for its dermal toxicity potential and relative skin irritancy when a single dose moistened with 1.0 mL ofdeionized 

### water/g test substance, at a level of2020 mg/kg, was applied to the intact skin ofalbino rats. No mortality occurred during the study. There were no clinical signs of toxicity or dermal irritation at any time throughout the study. There was no effect on bodyweight gain with the exception oftwo animals that lost weight duringthe 1 sI week. The gross necropsy conducted at termination ofthe study revealed no observable abnormalities. The estimated LD5Q, as indicatedbythe data, was determined to be greater than 2020 mg/kg. INTRODUCTION The objective ofthis study was to assess the systemic toxicity potential and relative skin irritancy ofthe test substance when administered to rats in accordance with US OECD 402, OPPTS 870.1200, and Canadian notification. This study was conducted for Sasol Germany GmbH,. according to the approved protocol and STILLMEADOW, Inc. SOPs. There were no deviations from the protocol that affected the quality or outcome ofthe study. All procedures in this study are in compliance with Animal Welfare Act Regulations. The protocol, raw data, this report and a sample oftest substance are archived at STILLMEADOW, Inc. The study was initiated on 11 Sep 09, the pre-dose experimental portion began on 23 Sep 09, and the animals were treated as follows: Dose Level Male Treatment Female Treatment In-life Termination Date mglkg Date 

# I Time Date 

# I Time Males 

# I Females 2020 24 Sep 09 

# I 0958 24 Sep 09 

# I 1002 08 Qct 09 i 08 Qct 09 

### I

Label Identification: Date & Quantity Received: Physical Description: Storage: Purity: Stability: TEST SUBSTANCE Alcohols, C18-22, distn. Residues CAS N0.1160164-88-4; LotNo. 035851MA; Spec: 59BIRN2 11 Sep 09; 246.3 g (GW) Tan solid Room temperature See Certificate ofAnalysis Exp: Aug 2013 perprovided information Data generated for characterization and stability and the level· of GLP compliance for that data is the responsibility ofthe sponsor. Records pertaining to identity, synthesis methods and location ofdocumentation are the responsibility ofthe sponsor. A copy ofthe Certificate ofAnalysis is included as reportAppendixA.

STILLMEADOW, Inc.Experimental Anima:ls Species & Strain: Justification ofSpecies: Source: Date BornlDate Received: Quarantine Period: Quantity & Sex: Animal/Group Identification: Weights onDosing Day: Animal Husbandry Cage Type: Housing: Environmental Controls TEST SYSTEM
Albino rat; Sprague-Dawley 13293-09 Page 6 of 11

The rat is a representative rodent species preferred byvarious regulatory agencies for use in an acute dermal study. Texas Animal Specialties, Humble, TX 21 Ju1 09110 Sep 09 5 days 5 male and 5 female (nulliparous and non-pregnant) Earpunch / Cage cards Male: 273-312 g; Female: 187-202 g Suspended, wire bottom, stainless steel 1per cage Setto Maintain: . Temperature 22°± 3° C .Relative Humidity 30-70%

. 10-12 air changeslhour . 12-hourlight/dark cycle Actual TemplRel. Humidity: 21-22° C / 50-94% Protocol deviation: Relative humiditywas outside protocol range but did not affect study outcome. Food: PMIFeeds InC.TM Formulab #5008; available adlibitum Water: Municipal water supply analyzed byTCEQ WaterUtilities Division; tap water, available adlibitum (automatic system) Animal husbandry and housing at STILLMEADOW, Inc. comply with standards outlined in the "Guide for the Care and Use ofLaboratory Animals" (NRC Publ.). No contaminants were expected to have been present inthe feed or waterthat would have interfered with or affected the results ofthe study. PROCEDURES Test Substance Preparation and Administration Healthy albino rats werereleased from quarantine. Each animal was prepared onthe day priorto treatment by clipping the dorsal surface ofthe trunk free ofhair to expose not less than 10% ofthe total body surface area. Care was taken to avoid abrading the skin. Only those animals with exposure areas free ofpre-existing skin irritation or defects were used for this study. All animals were treated with 2020 mg/kg ofthe test substance. Each dose was moistened with a sufficient amount of deionized water (1.0 mL/g of test substance). An individual dose was calculated for each animal based on its Day 0 body weightjustbefore exposure. The test substance was applied evenly to each exposure area in a thin, uniform layer. The area of application was covered with a 2 x 4 in. surgical gauze patch and secured with non-irritating adhesive tape. The trunk ofeach animal was then wrapped with vet wrap that was secured in place with non-irritating adhesive tape to prevent possible ingestion ofthetest substance.

STILLMEADOW, Inc.

### Removal ofTest Substance 13293-09 

### Page 7 of 11
After 24 hours, the wrappings were removed. The test sites were gently washed with room temperature tap water and a clean cloth to remove as much residual test substance as possible. In-life Observations Observations for mortality and clinicallbehavioral,signs oftoxicity were made at least three times on the day ofdosing (Day 0) 

### and at least once daily thereafter for 14 days. Individual body weights were recordedjust priorto dosing and on Days 7 and 14. Dermal Irritation Observations Observations for evidence of dermal irritation were made at approximately 60 

### minutes after removal of wrappings, and on Days 4, 7, 11 and 14. Postmortem Observations On Day 14 after dosing, animals were euthanized by an overdose ofCO2 . 

### All study animals were subjectedto gross necropsy and all abnormalities were recorded. RESULTS AND DISCUSSION MortalitylEstimated LD50 Values There was no mortality during the study. The estimated acute dermal LD5o, as indicated by the data, was determined to be greater than 2020 

### mg/kg bodyweight. Body Weights Individual body weights are presented in Table 1. Body weight gain was unaffected by the administration of the test substance, with the exception of two females that lost weight slightly during Week 1, but gained weight during Week 2. Clinical SignslDermal Irritation Clinical signs oftoxicity are presented inTable 2. All animals appeared normal for the duration 6fthe study. There were no signs ofdermal irritation at any observationperiod. Necropsy Findings**Individu~l** 

### necropsy fmdings are presented 

### in Table 1. The gross necropsy conducted at termination ofthe studyrevealed no observable abnormalities.

STILLMEADOW, Inc.

### CONCLUSION 13293-09 Page 8 of11

The test substance, A1cohols, C18-22, distn. Residues (CAS No.l160164-88-4), was evaluated for its acute dennal toxicity potential and relative skin irritancy when administered to albino rats. The acute dennal LDso; as indicatedbythe data, is greater than 2020 mglkg in males and females. Study Director: Janic 0 Kuhn, PhD, DABT Date Se or oxicologist, STILL.MEADOW, Inc.

Technical Staff: Carol Morris, BA Nancy Casajuana, LAT Robert Preston Data Services: Jeanne Poonnan, BS Report'Preparation STUDYPERSONNEL Paul Siemens, BA Hector Fuentes

STILLMEADOW, Inc.

### TABLE 1- BodyWeights, Time ofDeath and Gross Necropsy Acute Dennal Toxicity Study in Rats Test Substance: Alcohols, C18-22, distn. Residues (CAS No.l160164-88-4) Dose Level: 2020 mg/kg An:imal Dose Body Weights Time of Number Amt (g) DayO 

### I Day 7 

### I Day 14 Death

### * 211-M 0.624 309 I 333 

## i 347 Day 14 I 212-M 0.630 312 

## I 330 

## I 349 Day 14 213-M 0.551 273 

## I 285 I 308 Day 14 I 214-M 0.606 300 

## I 322 

## i 350 Day 14 215-M 0.592 293 

## I 305 

## I 333 Day 14 216-F 0.400 198 

### ! 195 I 206 Day 14 I 217-F 0.408 202 

## I 190 

## I 201 Day 14**218~F** 0.408 202 

## I 205 I 217 Day 14 ! 219-F 0.378 187 

## I 196 

## I 211 Day 14 220-F 0.384 190 

## I 200 

## I 205 Day 14 

## * -Day ofdosing considered Day0; Day 14 is terminal sacrifice. M - Male; F - Female; NOA
- No observable abnormalities NOA NOA NOA NOA NOA NOA NOA NOA NOA NOA 13293-09 Page 9 of 11

Gross NecropsyFindings

STILLMEADOW, Inc.TABLE 2 - Pharmacologic and/or Toxicologic Signs Acute Dermal Toxicity Study 

### in Rats Test Substance: A1cohols, C18-22, distn. Residues (CAS No. 1160164-88-4) Dose Level: 2020 mg/kg Time AfterTreatment Reaction and Severity Males All normal at each observation Females All normal at each observation Day 0 Day 13293-09 Page 10 of 11

STILLMEADOw", Inc.13293-09 Page 11 of 11 

### APPENDIXA - Certificate ofAnalysis 

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### C E R T I FIe ATE 

### o F ANALYSIS

Product; Lot No.; Manufacturing date: Alcohols, C18-22, distn. Residues 03585/MA (59Bllm2) 25/08/2009 Expiry dat.e: 08/201.3

Unit Result

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- Number [tng KOH/5r] 50, Ester No. (mg xoa/g] 41.:1,7 Acid No. {mg }(OR/g] 0.09 Water [wt.%] 0,02 Iodine No. [l11g I/IOOmg} 5,34

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